Kornimate/medical-research-clean huggingface dataset:
individualized fortification of human milk for infants born ≤ 1250 g (maximom-inform)

Conditions: Very Low Birth Weight Infant

Summary: very low birth weight infants have increased nutritional needs. extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. standard fortification of human milk is routine in most neonatal units in north america, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. two individualized fortification methods, target and bun adjustable, have been proposed to improve the nutrient supply to infants. however, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or bun adjustable fortification methods until the end of the feeding intervention. feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. at 4 months ca, growth and body composition will be determined by air displacement plethysmography on a subset of infants. neurodevelopment will be assessed using the bayley scales of infant and toddler development, at 18-24 months ca.

the end of the feeding intervention is defined as: the infant is 36+0 weeks ca, is discharged home, or receives two oral feeds daily for three consecutive days without top-up. the exception to the 36+0 weeks intervention end-date is in the situation where an infant remains hospitalized but has not completed at least four weeks of the feeding intervention (i.e. 4 weeks following study day 1).

Eligibility criteria:
inclusion criteria: * ≤1250 g birth weight or gestational age \<30+0 weeks and \<1500 g birth weight. * parental/guardian consent to participate. * consent for the use of pasteurized donor milk if mother's milk is not available. exclusion criteria: * infant received fortifier or formula before study day 1. * study day 1 to occur after postnatal day 21. * infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment. * enrollment in any other clinical study affecting nutritional management during the feeding intervention. * reasonable potential that the infant will be transferred to a nicu where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.
adductor canal block (acb) versus acb /saphenous block in patients undergoing anterior cruciate ligament repair

Conditions: Postoperative Pain

Summary: knee surgeries are associated with severe postoperative pain. blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. it carries potential benefits that encourage anesthesiologists to do it. it has a motor sparing property. injection of local anesthetics in this lengthy canal that contains a variable amount of connective or fibrous tissue might lead to a patchy distribution of local anesthetics. thus, the possibility of incomplete block of the saphenous nerve (most important nerve in knee innervations) cannot be excluded.

aim of the study is to compare the efficacy of the adductor canal block to the combined adductor canal block and saphenous nerve block at the distal third of thigh in the intermuscular plane between vastus medialis and sartorius muscles in pain relief following knee arthroscopic anterior cruciate ligament repair. after written informed consent, patients will be randomized in three groups: group (adductor 20): ultrasound guided adductor canal block will be performed with injection of 20 ml bupivcaine 0.5%. group (adductor 30) ultrasound guided adductor canal block will be performed with injection of 30 ml bupivacaine 0.5%. group (adductor/saphenous ): ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine 0.5%, combined with ultrasound guided saphenous

Eligibility criteria:
inclusion criteria: * scheduled for knee orthopedic ( acl repair) * physical status asa i, ii. * body mass index (bmi): \> 20 kg/m2 and \< 35 kg/m2. exclusion criteria: * • patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids). * history of psychological disorders and/or chronic pain. * contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. * infection of the skin at the site of needle puncture area. * patient refusal. * severe respiratory or cardiac disorders. * advanced liver or kidney disease. * pregnancy. * patient with surgery duration more than two hours.
feasibility of lymphocyte reinfusion in newly diagnosed high grade gliomas

Conditions: Glioblastoma

Summary: this research study is being done to see if lymphocytes can be collected from patients with high grade gliomas before they start standard radiation and chemotherapy. (lymphocytes are cells that normally circulate in the blood and are an essential part of the immune system). the investigators goal is to store these and give them back to the patient after radiation is completed. this is part of a larger effort that will attempt to preserve the immune system from the effects of radiation and chemotherapy.

the patients blood will be collected (apheresis) before starting the patients planned standard of care radiation therapy and chemotherapy: * an iv will be inserted into the vein in the patients arm. * the blood will be sent to a machine that removes the lymphocytes and returns the rest to the patient. * this procedure will last from 1 hour and 15 minutes to 4 hours. * during this time the patient will also be treated with a blood thinner to prevent the blood from clotting in the machine. * the lymphocytes will be counted and stored. if an insufficient number were collected, we will ask for another similar collection in about 1 week. * after the patient has completed the full 6 weeks of radiation, all of the lymphocytes will be returned to the patient through a simple intravenous infusion. a larger intravenous access (i.e. midline) might be needed. any cells that are not reinfused will be stored for 1 year and then discarded. * study bloods (10 ml) will be collected at the time of lymphocyte collection, prior lymphocyte reinfusion, and then every 2 weeks until week 20th. these blood samples will be stored and used for future analysis. blood counts are obtained weekly as part of standard care for patients with this kind of brain tumor. for the first 14 weeks after the lymphocyte reinfusion we will be doing some extra tests on the routinely collected blood to see how the effective the reinfused lymphocytes are in raising the patients lymphocyte counts. these results will be available to the patients treating physician. at no time will this study interfere with the patients planned standard of care radiation and chemotherapy.

Eligibility criteria:
inclusion criteria: * • age≥18 year * new diagnosed high grade glioma * post-operative treatment with standard rt/tmz * karnofsky performance status ≥ 60% * normal bone marrow function with hematocrit ≥ 30%, platelet ≥ 100k, anc ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study. blood product transfusions are allowed. exclusion criteria: * prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents or hormonal therapy for their brain tumor are excluded. glucocorticoid therapy is allowed. * fresh cns bleed, current anticoagulation use; and anti-vegf therapy in past 6 weeks are excluded. * patients must not have taken an ace inhibitor within last 24 hours prior to apheresis.

Keywords: lymphopenia
paraurethral transplantation of autologous muscle derived stem cells for treatment of stress incontinency

Conditions: Stress Urine Incontinency

Summary: this study was designed to provide confirmation of efficacy of muscle derived stem cells (mdcs) for the treatment of sui in women.

the investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. a total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. assessments will be made at 1, 3, 6 and 12 months after cell injection. changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.

Eligibility criteria:
inclusion criteria: * female * stress urinary incontinence symptoms * urodynamic stress incontinence confirmed with multichannel urodynamic testing * positive cough stress test * urgency score \< stress score * patient's age between 40 - 65 years * desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of sui exclusion criteria: * post-void residual volume \>100cc * detrusor overactivity on preoperative multichannel urodynamic testing * history of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra * desires future childbearing * chronic inguinal or vulvar abscess or history of hidradenitis suppurative * history of bleeding diathesis or current anti-coagulation therapy * inguinal lymphadenopathy or inguinal/vulvar mass * current genitourinary fistula or urethral diverticulum * current sever cystocele or rectocele * active urinary infection * non-treated urge incontinency or any significant voiding dysfunction * neuromuscular disorders * uncontrolled diabetes * reversible cause of incontinence (i.e. drug effect) * contraindications for surgery

Keywords: autologous stress urinary incontinence muscle derived cells
studies of the ocular complications of aids (soca)--cytomegalovirus retinitis retreatment trial (crrt)

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Retinitis

Summary: to compare the relative merits of three therapeutic regimens in patients with aids and cmv retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. these three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. to compare two treatment strategies in patients with relapsed or nonresponsive cmv retinitis: (1) continuing the same anti-cmv drug or (2) switching to the alternate drug.

cmv retinitis is the most common intraocular infection in patients with aids and is estimated to affect 35 to 40 percent of patients with aids. untreated cmv retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. at the time of this trial, drugs approved by the united states food and drug administration (fda) for the treatment of cmv retinitis were ganciclovir (cytovene) and foscarnet (foscavir). although most retinitis responds well to initial therapy with systemically administered drugs, given enough time, nearly all patients will suffer a relapse of the retinitis. relapsed retinitis generally responds to reinduction and maintenance therapy, but the interval between successive relapses progressively shortens. the crrt addressed the issue of the management of relapsed cmv retinitis. the crrt was a multicenter, randomized, controlled clinical trial comparing three regimens in patients with relapsed retinitis. patients with aids and cmv retinitis that had relapsed or was nonresponsive to initial therapy were randomized to one of three regimens: (1) intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.

Eligibility criteria:
inclusion criteria: males and females eligible for the crrt must have been age 18 years or older and have had aids and cmv retinitis. they must have had active cmv despite a minimum of 28 days of previous treatment with an anti-cmv drug. furthermore, they must have had an absolute neutrophil count greater than or equal to 500 cells/µl, platelet count greater than or equal to 20,000 cells/µl, and a serum creatinine \< 2.5 mg/dl in order to tolerate the drug regimens. exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment not scheduled for surgical repair
dual anti-her2 therapy (lapatinib and trastuzumab) plus chemotherapy in her2-positive mbc

Conditions: Breast Cancer

Summary: to explore the real world situation of trastuzumab and lapatinib combined chemotherapy in china, and to explore the relationship between progression free survival and treatment.


Eligibility criteria:
inclusion criteria: * 1. woman, age \> 18 years old 2. diagnosed with her2 +metastatic breast cancer 3. dual anti-her2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. available medical history exclusion criteria: * 1. incomplete medical history
modified foot exercise to improve sensitivity and perfussion on type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: subject will be trained to do regular foot exercise during their visit to the clinic. we will evaluate foot sensitivity and peripheral perfussion after

use an 8-10 mhz doppler probe with a gel smeared over the sensor. place the doppler probe on the pulse area at a 45-60° angle to the skin surface. move the probe to find the most precise and robust arterial pulse before inflating the cuff. the cuff is inflated about 20 mm hg above the point where the arterial doppler sound disappears. then slowly deflate until the doppler sound reappears and records this value. the blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel. if the flow is still detected at the maximum inflation rate (300 mmhg), the cuff should be deflated immediately to avoid pain.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 exclusion criteria: * chronic heart failure * chronic kidney diseae

Keywords: foot exercise, diabetes mellitus type 2
advanced mri in aaa

Conditions: Abdominal Aortic Aneurysm

Summary: this study aims to determine whether advanced mri sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (aaas). the mri sequences will study outcomes related to blood flow inside aaa, microvasculature of the aaa vessel wall and intraluminal thrombus inside aaa. robustness of these mri sequences will be determined with testing of feasibility and reproducibility. clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. disease severity will be expressed by aaa diameter. it is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.

this prospective study evaluates the feasibility, reproducibility and clinical relevance of mri sequences in adults with an abdominal aortic aneurysm (aaa). the mri sequences and their primary outcomes are: * four-dimensional (4d) flow mri and wall shear stress (wss) * dynamic contrast-enhanced (dce) mri and kinetic transport constant (ktrans) * t1 and t2 mapping (t1 and t2 relaxation times) feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes. reproducibility is tested by calculating interscan, intra- and interobserver variability. clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by aaa diameter

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years of age) * abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm exclusion criteria: * contra-indications for mri * severely reduced renal function (egfr \< 30) * previous allergic reaction to intravenous contrast agents * suprarenal aaa * pararenal aaa * previous aneurysm repair * inflammatory aneurysm * mycotic or other infectious aneurysm * vasculitis * connective tissue disease

Keywords: abdominal aortic aneurysm 4d flow mri dce-mri t1 and t2 mapping
palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer

Conditions: Hormone-refractory Prostate Cancer

Summary: the aim of the present feasibility study of a new short palliative radiotherapy regime that apply to patients with metastatic hormone refractory prostate cancer (hrpc) presenting with a dominating debilitating symptom. diffusion weighted magnetic resonance imaging (dwi) will apply to identify both the lesion and the most aggressive part of the lesion. the symptomatic lesions will be treated with a dose of 4 x 5 gy, while for the most aggressive part of the lesion the dose will be escalated to 4 x 7 gy using a simultaneous integrated boost (sib) technique.

please refer to uploaded study protocol

Eligibility criteria:
inclusion criteria: 1. patients with hormone refractory biopsy proven prostate cancer 2. presenting with a dominating debilitating symptom 3. expected median survival of 12 months 4. focal irradiation of lesion is feasible 5. systemic therapy according to guidelines 6. age ≥18 years 7. legal capacity, able to understand consequences of the trial 8. written informed consent exclusion criteria: 1. relevant comorbidity (limiting radiotherapy according to protocol) 2. prior radiotherapy limitations to administer radiotherapy according to protocol 3. no large metal implants in vicinity of lesion 4. department dose constraints for normal tissue can't be met 5. large bony lesions with extensive osseous destruction 6. patients symptoms do not correlate with mr findings
lumbar drain after endoscopic surgery of the skull base

Conditions: Quality of Life

Summary: the overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (eea) surgery in reducing cerebrospinal fluid (csf) leak postoperatively and promote a standardization of its use.

in the past, reconstructions were performed using fat grafts or fascia lata for eea surgery. considerably high postoperative csf leaks were reported and were a major cause of concern due csf fistula increasing risk of infection. since external lumbar drain can lower csf pressure and is believed to prevent post operative csf leak, it was used commonly after eea. with improvements in eea skull base reconstructions using a nasal septal flap in the recent years, postoperative csf leaks have been reported in much lower rates. with this improvement in reconstruction techniques, the use of lumbar drain may not be necessary as it may not significantly lower the risk of csf leak further. in this prospective randomized study, we will randomize subjects at high risk for csf leak to either receive a prophylactic lumbar drain or to not receive a prophylactic lumbar drain and compare the rate of csf leaks and other complications in the two groups.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients undergoing eea for resection of brain tumors * dural defect greater than 1cm * extensive arachnoid dissection * dissection into a ventricle or cistern exclusion criteria: * less than 18 years of age * spina bifida

Keywords: lumbar drain, csf leak
a comparative study of the efficacy of penciclovir 10mg/g (1%) cream in preventing the appearance of classical lesion in recurrent cold sore sufferers

Conditions: Cold Sore

Summary: comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.


Eligibility criteria:
inclusion criteria: * be known to be a cold sore sufferer and presenting a prodromal stage with pain * sign the written informed consent form prior to enrolment in the trial; * be aged 18 to 75 years; exclusion criteria: * if female, are pregnant, planning pregnancy or lactating; * have a known hypersensitivity to penciclovir or any ingredients of the vehicle; * have already ongoing classical cold sore lesions at the baseline visit; * have taken any cold sore product, analgesic or nsaid in the 24 hours before the baseline visit; * have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment; * are known to be immunosuppressed (acquired, congenital or therapeutic); * have been involved in any investigational protocol within the 30 days prior to the trial; * have evidence or history of drug or alcohol abuse;

Keywords: cold sore
pediatric asthma study using stepwise treatment with two food and drug administration approved asthma medications

Conditions: Asthma

Summary: this study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (pd20 methacholine).


Eligibility criteria:
inclusion criteria: * children with a documented history of asthma. * using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start. * must be able to perform reproducible lung function tests. * must have a positive rast or skin prick test. * during the treatment period, the patient has to be hyperreactive (defined as pd20 methacholine \< 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period. exclusion criteria: * history of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1. * admitted to hospital due to a respiratory disease 4 weeks prior to visit 1. * received oral corticosteroids within 4 weeks prior to visit 1. * existence of any disorder that affects growth. * clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting b2-agonists.

Keywords: children asthma bronchial hyperresponsiveness symptoms